Leeann Chrisco Email & Phone Number

Director with extensive industry experience in biopharmaceuticals, monoclonal antibodies, gene therapy, vaccines, and microbial GMP manufacturing operations, regulatory compliance, and quality assurance. I bring expertise in regulatory affairs, including authoring and reviewing CMC sections for INDs, IMPDs, BLAs, MAAs, NDAs, and ROW, and a thorough knowledge of cGMP and ICH guidelines. I proactively manage the Chemistry, Manufacturing & Controls (CMC) aspects of biologic products, ensuring high-quality regulatory submissions that support product development strategy through cross-functional collaboration.With over fifteen years of experience in Quality Assurance, I specialize in auditing, GMP manufacturing, commercial material management, and documentation compliance. My experience also includes technology transfer and validation, where I have been responsible for improving manufacturing efficiency and ensuring data integrity compliance. I have a strong analytical and technical background, which enables me to work both independently and as an effective team member in fast-paced environments. Furthermore, my communication skills and attention to detail, proficiency in MS Office, and experience in using validated Regulatory Information Management systems make me a valuable asset to any team.My areas of expertise include Regulatory CMC SME, Vault eQMS, Veeva RIM, GMP Manufacturing Production Authority, Project Management, Project Leadership, Product Lifecycle Management, Regulatory Documentation, Data Verification, Technical Writing, Change Management, Clean Room Design, Facility training & development, Facility Commissioning & Validation, LIMS, Quality Investigations, SAP, Critical Analysis, GMP & ICH Guidelines, Six Sigma Green Belt, M1 Facilitator, Clean Room Gowning.I've also demonstrated strong leadership skills, having led several teams, including Site Transfer Teams, Biologic Management Technology Strategy Sub-Team, the Technical Transfer procedure team, and the Pfizer Women Leadership Network Colleague Resource Group. Additionally, I serve as a mentor for the Healthcare Businesswomen's Association global network and was a core team member representing GMP manufacturing and GMP analytical testing groups for a new facility.